Below is a run-down of our advocacy highlights in 2023. The easiest way to get involved with our legislative outreach is to visit the RNS Action Center. Please get in touch with us via firstname.lastname@example.org if you have questions or would like more information!
2023 Advocacy Summit
In March, RNS members from twelve states traveled to Washington, D.C. to spend the day on Capitol Hill. We began the event by hearing from Representative Buddy Carter (R-GA), who is a pharmacist by background, as well as two nurses currently serving in Congress: Representatives Lauren Underwood (D-IL) and Jen Kiggans (R-VA). During our Hill visits, we visited with health staff and Members in over forty House and Senate offices. We educated policymakers about issues affecting rheumatology patients, including the impacts of utilization management protocols on patient care, as well as the burden of high out-of-pocket costs for specialty medications. To help support rheumatology patients on these issues, we advocated reform of prior authorization via the Improving Seniors’ Timely Access to Care Act and step therapy via the Safe Step Act. Additionally, we urged advancement of the HELP Copays Act, which would ensure that patients can fully access the value of copay assistance.
The Fight Over Copay Assistance
On the topic of copay assistance, this year was an incredibly active one. Copay accumulators and maximizers are programs by insurance companies and pharmacy benefit managers (PBMs) that prevent patients from accessing the full value of cost-sharing assistance they receive from drug companies. Because these kinds of programs increase out-of-pocket costs for patients, they are considered incredibly harmful by patient and prescriber groups. In 2023, RNS joined an amicus brief in litigation challenging the use of these insurer programs in Affordable Care Act plans. In the fall, the court vacated the regulation allowing the indiscriminate use of these programs, which was a major victory for us and our allies. Unfortunately, the Administration plans to appeal that ruling, despite requests from both the All Copays Count Coalition and bipartisan Members of Congress to let the ruling stand and return to the previous regulatory paradigm instead, which allowed use of these programs only for branded drugs that have low-cost therapeutic alternatives. The uncertainty makes it all the more important to advance the HELP Copays Act, which would codify a prohibition on the use of accumulators, so we will continue to push that legislation in 2024. Not only was that legislation on our list for our in-person Advocacy Summit, we also have an ongoing grassroots campaign on it, which you can access here.
A Year of Bipartisanship on Pharmacy Benefit Manager (PBM) Reform
One issue that both major political parties broadly agree on is that it’s long past time to reform the PBM industry. For an indication of just how broad that agreement is, look no further than the Senate Finance Committee, which unanimously advanced comprehensive PBM reform legislation in November. On the House side, several key policies also advanced with strong support, including a policy to “delink” drug prices from PBM income. Although drug pricing policies can get complex, this intuitive reform is simple: currently, the higher a drug’s list price, the higher the income potential for the PBM, because the PBM negotiates percentage-based “concessions” off the list price. That creates a perverse incentive for the PBM to prefer drugs with higher list prices on formularies. In turn, that harms patients, whose coinsurances are often based on those high list prices. See here for a particularly egregious example of this behavior, but even beyond anecdotal evidence, researchers at the University of Southern California have quantified the correlation between list prices and price concessions to the PBM, finding that for every $1 increase in rebates, there’s a $1.17 increase in list price.
Fortunately, lawmakers of all political persuasions have identified this as a major misalignment in our drug pricing system, which is why both chambers are considering “delinking” policies for both Medicare and commercial plans. Another policy that was advanced by the Senate Finance Committee is a requirement for the PBM to “pass through” the discounts and other price concessions it negotiates directly to the patients in the form of reduced out-of-pocket costs.
RNS has been engaged in these reform efforts directly and through the Alliance for Transparent and Affordable Prescriptions, a coalition of patient and provider groups dedicated to PBM reform. The last year left in the 118th Congress is a presidential election year, which usually means that not much substantive policy reforms are enacted, but there’s such bipartisan momentum behind PBM reform that we may very well end 2024 with significant, meaningful PBM reform on the books.
RNS Education on Biosimilars
Biosimilars continued to be a hot topic in 2023 as well. Congress considered (though ultimately has not yet advanced) proposals to eliminate the interchangeability standard from the biosimilars application process at FDA. Currently, the statute distinguishes between biosimilars and interchangeable biosimilars, with the latter requiring a manufacturer to show that switching between the reference product and the interchangeable biosimilar product is not expected to increase the safety risks or decrease efficacy. When that showing is made, the biosimilar is deemed “interchangeable” by FDA. Increasingly, insurers are essentially ignoring this paradigm by forcing patients to switch to non-interchangeable biosimilars, which has led some policymakers to reconsider whether the interchangeability standard is still necessary. That debate may get additional airtime in 2024, which made our “Breaking Down Biosimilars” educational town hall series especially timely this year. In September, we hosted Dr. Sarah Yim from the Food and Drug Administration for a session, and the topic of interchangeability came up – if you missed the event, you can access it here.
Medicare Coverage of Self-Administered versus Provider-Administered Medications
The Inflation Reduction Act (IRA) requires Medicare to directly establish prices for certain selected Part B and D drugs, starting with Part D drugs first. In 2023, the Centers for Medicare and Medicaid Services (CMS) issued the list of the first ten Part D drugs selected for the new program, which included Enbrel and Stelara. Since these are commonly used medications in rheumatology, RNS took advantage of the opportunity that CMS offered the public to provide feedback. Specifically, we wanted to highlight that Stelara has both a provider-administered and a self-administered version, but that accessing the provider-administered version has become almost impossible for many Medicare beneficiaries. Not only does that create financial barriers for these patients, it also leaves beneficiaries who cannot self-administer without access to the medication. The access issues with drugs that have dual formulations have gotten so severe that CMS is currently reevaluating the process by which its contractors exclude medications in this situation from Part B coverage. In our feedback to CMS, we urged the agency to ensure that it does not inadvertently exacerbate the existing challenges for beneficiaries who need the provider-administered version of Stelara.